1. Field of the Invention
The present invention relates to an improved catheter packaging system for use particularly, but not exclusively with a percutaneous translumenal coronary angioplasty (PTCA) catheter.
2. Description of the Related Art
Catheters typically have fittings or accessories of some kind on their proximal end, that is to say, the end of the catheter which, in use, is not contained within the patient's body. PTCA or balloon catheters generally have a luer fitting at the proximal end and will usually have one or more shaft accessories, such as a wire lock device and an anti-backbleed device. The bulk of the length of the catheter is typically packaged within a robust dispenser tube, which protects the balloon located on the distal end of the shaft and the shaft itself from accidental damage during storage, transit and preparations for use. Normally, the dispenser tube is coiled to enable the product to be packaged more compactly. The proximal end of the catheter comprising the luer fitting and shaft accessories projects clear of the tube so that it is presented free for use by the physician. The distal end of the catheter, which includes the delicate balloon, is retained safely within the coiled dispenser. While the distal end is securely protected during transit and storage, the proximal end is subject to damage in these phases. It will be appreciated that any movement of the package which tends to move the exposed proximal end relative to the dispenser is likely to cause kinking of the catheter which renders it useless. Furthermore, incorrect removal of the catheter from its package can cause kinking of the catheter. For example, if there is a lateral component to the substantially axially applied force (relative to the longitudinal axis of the dispenser) used to withdraw the catheter from the dispenser, this can induce a kink in the catheter. Likewise, exertion of a rotational force can cause the catheter to rotate within the coiled dispenser, but since such rotational freedom is resisted by the coiling of the dispenser, damage to the catheter shaft can result.
Packages for catheters are known in which the proximal end and its accessories are presented to the physician in the correct orientation for removal. In one such packaging device, a thermoformed plastics clip is provided which is shaped to receive and retain the luer fitting and accessories as a snap-fit. The clip is also shaped to retain the proximal end of the coiled dispenser so that prior to use, the dispenser, catheter and proximal end accessories are fixed together, the presentation being the one required for correct removal of the catheter from the dispenser. This can be achieved by removing the luer fitting and accessories from the thermoformed clip, then withdrawing the catheter. In practice, it has been found that in the busy environment of the hospital, there is a tendency for the luer to be pulled out of the clip in a motion which is at an angle to the longitudinal shaft of the catheter and, as described above, this can result in damage to the shaft. Additionally, it has been found that since the clip is relatively weak, it is susceptible to breakage during transit and storage and this can result in shaft damage.
In another known package, a sleeve is formed on or fixed to the proximal end of the dispenser and sized to receive and retain the accessories and a portion of the luer fitting. The luer fitting projects from the sleeve so that it can be grasped to withdraw the catheter from the dispenser. While this arrangement is quite successful, it is frequently the case that when the luer is withdrawn, one or more of the accessories remains within the sleeve.